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A Randomized Phase III Trial of Adjuvant Therapy Comparing Chemotherapy Alone (Six Cycles of Docetaxel Plus Cyclophosphamide or Four Cycles of Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel) to Chemotherapy Plus Trastuzumab inWomen with Node-Positive or High-Risk Node-Negative HER2-Low Invasive Breast Cancer
Overall Recruitment Status: Enrollment complete
 
Official Title
A Randomized Phase III Trial of Adjuvant Therapy Comparing Chemotherapy Alone (Six Cycles of Docetaxel Plus Cyclophosphamide or Four Cycles of Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel) to Chemotherapy Plus Trastuzumab inWomen with Node-Positive or High-Risk Node-Negative HER2-Low Invasive Breast Cancer
 
Region Sponsors
Colorado
National Cancer Institute (NCI)
 
Acronym NCT No.
NCT01275677
 
Study Type Phase
Clinical Trial
Phase III
 
Purpose
This randomized phase III clinical trial studies chemotherapy with or without trastuzumab after surgery to see how well they work in treating women with invasive breast cancer. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) and giving chemotherapy after surgery may kill more tumor cells. Monoclonal antibodies, such as trastuzumab, can block cancer growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether combination chemotherapy is more effective with trastuzumab in treating breast cancer.
 
Detailed Description
 
 
 
Inclusion Criteria
  • Patients should have a life expectancy of at least 10 years, excluding their diagnosis of breast cancer
  • (comorbid conditions should be taken into consideration, but not the diagnosis of breast cancer)
  • Women of reproductive potential must agree to use an effective non-hormonal method of contraception (for example condoms, some intrauterine devices, diaphragms, tubal ligation, vasectomized partner, or abstinence) during therapy and for at least 6 months (Arm 1 patients) and for at least 7 months (Arm 2 patients) after the last dose of study therapy (chemotherapy or trastuzumab)
  • Submission of tumor samples from the breast surgery is required for all patients
  • therefore, the local pathology department policy regarding release of tumor samples must be considered in the screening process
  • patients whose tumor samples are located in a pathology department that by policy will not submit any samples for research purposes should not be approached for participation in the B-47 trial
  • The patient must have signed and dated an Institutional Review Board (IRB)-approved consent form that conforms to federal and institutional guidelines
  • Eastern Cooperation Oncology Group (ECOG) performance status of 0 or 1
 
Exclusion Criteria
  • Primary tumor with any of the following HER2 testing results: IHC staining intensity: 0 on all evaluations of specimens 3+ on evaluation of any specimen ISH with a ratio of HER2 to CEP17 >= 2.0 on evaluation of any specimen ISH result indicating HER2 gene copy number >= 4 per nucleus on evaluation of any specimen
  • T4 tumors including inflammatory breast cancer
  • Definitive clinical or radiologic evidence of metastatic disease NOTE: Chest imaging (mandatory for all patients) and other imaging (if required) must have been performed within 90 days prior to randomization
  • Synchronous or previous contralateral invasive breast cancer (patients with synchronous and/or previous contralateral DCIS or LCIS are eligible)
  • Any previous history of ipsilateral invasive breast cancer or ipsilateral DCIS
  • (patients with synchronous or previous ipsilateral LCIS are eligible)
 
Keywords and/or Specific Medical Conditions
  • Obstetrics and Gynecology
  • Oncology (Adult)
 
KP Clinical Facility
  • Lone Tree Medical Offices - Lone Tree
 
Clinical Area
  • Obstetrics and Gynecology
  • Oncology (Adult)


Principal Investigator:
Alex Menter
Contact Information:
- CTP Team
-ctpcollaborate@kp.org
-Lone Tree Medical Offices - Lone Tree


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